메뉴 건너뛰기




Volumn 40, Issue 6, 2013, Pages 449-452

Whither advanced therapy medicinal products?

Author keywords

[No Author keywords available]

Indexed keywords

CHONDROCYTE IMPLANT;

EID: 84896524410     PISSN: 16603796     EISSN: 16603818     Source Type: Journal    
DOI: 10.1159/000356514     Document Type: Note
Times cited : (3)

References (22)
  • 1
    • 84896533755 scopus 로고    scopus 로고
    • European Union: Regulation (EC) No 1394/2007 of the European Parliament and of the Council
    • European Union: Regulation (EC) No 1394/2007 of the European Parliament and of the Council. 2007.
    • (2007)
  • 2
    • 84896498689 scopus 로고    scopus 로고
    • European Union: Commission Directive 2009/120/EC. 2009
    • European Union: Commission Directive 2009/120/EC. 2009.
  • 3
    • 84896506863 scopus 로고    scopus 로고
    • European Union: Council Directive 93/42/EEC. 2008
    • European Union: Council Directive 93/42/EEC. 2008.
  • 4
    • 84896534606 scopus 로고    scopus 로고
    • European Union: Directive 2004/23/EC of the European Parliament and of the Council
    • European Union: Directive 2004/23/EC of the European Parliament and of the Council. 2004.
    • (2004)
  • 5
    • 84896519197 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration: Guidance for Industry: Regulation of Human Cells Tissues and Cellular and Tissue-Based Products (HCT/Ps)-Small Entity Compliance Guide. Available from
    • U.S. Food and Drug Administration: Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)-Small Entity Compliance Guide.Available from: www.fda.gov/BiologicsBloodVaccines/ Guidance-ComplianceRegulatoryInformation/Guidances/Tissue/ucm073366.htm.
  • 6
    • 84857756807 scopus 로고    scopus 로고
    • Clinical development of advanced therapy medicinal products in Europe: Evidence that regulators must be proactive
    • Maciulaitis R, D'Apote L, Buchanan A, Pioppo L, Schneider CK: Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive. Mol Ther 2009; 20:479-482.
    • (2009) Mol Ther , vol.20 , pp. 479-482
    • MacIulaitis, R.1    D'Apote, L.2    Buchanan, A.3    Pioppo, L.4    Schneider, C.K.5
  • 7
    • 84928170788 scopus 로고    scopus 로고
    • Notorious stem cell therapy centre closes in Germany
    • Notorious stem cell therapy centre closes in Germany. Nature News Blog. http://blogs.nature.com/news/2011/05/notorious-stem-cell-therapy-ce-1. html.
    • Nature News Blog.
  • 8
    • 79751514470 scopus 로고    scopus 로고
    • XCell-Center: Das Dilemma der Übergangsfrist
    • A-2499/B-2171/C-2127
    • Zylka-Menhorn V: XCell-Center: Das Dilemma der Übergangsfrist. Dtsch Ärztebl 2010;107:A-2499/B-2171/C-2127.
    • (2010) Dtsch Ärztebl , pp. 107
    • Zylka-Menhorn, V.1
  • 9
    • 70249145083 scopus 로고    scopus 로고
    • Trading on hope
    • Qiu J: Trading on hope. Nat Biotechnol 2009;27: 790-792.
    • (2009) Nat Biotechnol , vol.27 , pp. 790-792
    • Qiu, J.1
  • 10
    • 84896503002 scopus 로고    scopus 로고
    • European Medicines Agency: Fee Reductions/Deferrals for micro, small and medium-sized enterprises (SMEs). Available from
    • European Medicines Agency: Fee Reductions/Deferrals for micro, small and medium-sized enterprises (SMEs). 2005. Available from: www.ema.europa. eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2009/10/ WC500004165.pdf.
    • (2005)
  • 11
    • 84896520895 scopus 로고    scopus 로고
    • European Medicines Agency: Minutes of the 78th meeting of the Management Board Available from
    • European Medicines Agency: Minutes of the 78th meeting of the Management Board. 2013. Available from: www.ema.europa.eu/docs/en-GB/document-library/ Minutes/2013/03/WC500140773.pdf.
    • (2013)
  • 12
    • 84896537603 scopus 로고    scopus 로고
    • European Union Council Regulation (EC) No 297/95. 2006
    • European Union: Council Regulation (EC) No 297/95. 2006.
  • 18
    • 84896524655 scopus 로고    scopus 로고
    • Available from
    • European Medicines Agency-Find medicine-ChondroCelect. Available from: www.ema.europa. eu/ema/index.jsp?curl = pages/medicines/human/medicines/000878/ human-med-000698.jsp and mid = WC0b01ac058001d124.
    • European Medicines Agency-Find Medicine-ChondroCelect
  • 19
    • 84896524655 scopus 로고    scopus 로고
    • Available from
    • European Medicines Agency-Find medicine-Glybera. Available from: www.ema.europa.eu/ema/index.jsp?curl = pages/medicines/human/medicines/002145/ human-med-001480.jsp and mid = WC0b01ac058001d124.
    • European Medicines Agency-Find Medicine-Glybera
  • 20
    • 84896524655 scopus 로고    scopus 로고
    • Available from
    • European Medicines Agency-Find medicine-Maci. Available from: www.ema.europa.eu/ema/index.jsp?curl = pages/medicines/human/medicines/002522/ human-med-001660.jsp and mid = WC-0b01ac058001d124.
    • European Medicines Agency-Find Medicine-Maci
  • 21
    • 84896524655 scopus 로고    scopus 로고
    • Available from
    • European Medicines Agency-Human medicines-Provenge. Available from: www.ema.europa.eu/ema/index.jsp?curl = pages/medicines/human/medicines/002513/ smops/Positive/human-smop-000538. jsp and mid = WC0b01ac058001d127.
    • European Medicines Agency-Human Medicines-Provenge


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.